PHA 5128 Case Study # 4. Enter New Patient in Patient Assessment: Select Patient / New Patient and enter all information.

Transcription

1 1. Gertrude Thompson MR #: Account #: Admission Date: 7/18/94 Physician: Jack Long, Infectious Disease Location: 4 West, Room 408, Bed C Female Black DOB: 2/5/ (163 cm), 220 lbs. (99.79 kg) PHA 5128 Case Study # 4 Gertrude is an overweight woman with a kidney infection. She has been admitted to the hospital with low back pain, fever, and chills. Lab results show an elevated WBC. The diagnosis is pyelonephritis. She has a long history of lower urinary tract infections, with no other complicating diseases except obesity. Serum creatinine is 0.7 mg/dl and stays stable with twice weekly monitoring. She is currently on Ampicillin PO 500 mg Q6H and Gentamicin IVB 80 mg Q8H over 20 min. which began at 8:00 am, 7/19/94. After 48 hours fever persists. Since aminoglycosides distribute to IBW plus 40% of fat tissue, the problem of inadequate antibiotic dosage is identified. Physician orders a Kinetics consult. Enter New Patient in Patient Assessment: Select Patient / New Patient and enter all information. Document the Patient s Baseline Condition (OPTIONAL): Select Profiles / Drug Usage. Click on New. Select the drug, enter the therapy start date, and select the prescribing physician. Click on OK. Click on Baseline and respond to the criteria accordingly. A sample of the baseline report is attached. Define the Simulation in Kinetics: Access the Kinetics System. Select Simulation / New Simulation. Select the appropriate drug (Gentamicin), enter the start date (07/19/94), the start time (08:00 am), and accept the default starting concentration (0). If you do not wish to enter previous dosage regimens, you may enter the last known drug concentration in this field. Click on OK. Select the appropriate indication (Pyelonephritis) and click on OK. Enter Renal Function Values: Select Kinetics / Renal Function and enter the date the value was obtained (07/19/94), the time the value was obtained (08:00 am), and the serum creatinine (.7). The creatinine clearance is automatically calculated. Click on Add. Click on OK. Enter Previous Dosage Regimens: Select Kinetics / Dosage Regimens. Select the type of dose (maintenance), select the route (IVB), enter the dose (80), the duration (20), the interval (8), the number of doses given (6), and the prescribing physician (Jack Long, Infectious Disease). Click on Add. Click on OK. Obtain Rx Recommendations: Select Kinetics / Rx Recommendations. Select the appropriate route and click on Generate Rx. Click on an appropriate regimen and click on Customize Rx to customize it to a practical dose. Select the newly customized regimen from the list of options and click on Select Rx. You may follow this procedure to customize and select more than one dose if D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 1

2 you wish to recommend different options. Click on OK and they will be graphed. Recommend follow up serum drug concentrations and meet with the patient to explain therapy. Step 9. Enter Serum Drug Concentrations: Select Kinetics / Serum Drug Concentrations. Enter the date, time, and value of each SDC. Click on Add after entering each SDC. SDCs obtained on 7/22/94 reveal a trough of 1.2 mcg/ml at 7:30 am and a peak of 7.1 mcg/ml at 9:10 am. Click on OK after entering both SDCs. The SDCs will appear as triangles on the graph. Curve Fit the Serum Drug Concentrations: Select Kinetics / Curve Fitting. Select the Analysis Type (Multiple Point) and select the SDCs. Click on Analyze. Click on Accept. Click on OK and the SDCs will be curve fit. Edit the Graph (OPTIONAL): Select Graph / Set X-Axis. Both the units (hours or dates) and the range can be edited to your liking. Simply click on the appropriate options and enter the desired range to be displayed. Click on OK and the graph will redraw to your specifications. Select Graph / Tracer or click on the Tracer button at the bottom of the screen or press F7 to access the graph tracer. Exact concentrations can be located at any point along the graph by clicking on the graph or by using the buttons to move the cursor by regimen, dose, or single increments. Exit Tracer by one of the same methods used to access it. Step 10. Save the Consult: Select Simulation / Save Simulation As and enter a name for the simulation. Click on OK. Step 11. Document the Patient s Interim/Final Condition (OPTIONAL): Access Patient Assessment and select Profiles / Drug Usage. Select the appropriate therapy and click on Int/Final. Respond to the criteria accordingly. A sample of the interim/final report is attached. The chart review indicates a temperature of 98.7º, WBC = 5,000 cells/mm 3, with no patient complaints. Step 12. Save the Patient Record: Select Patient / Save Patient. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 2

3 2. John K. Williams MR #: Account #: Admission Date: 8/01/94 Physician: Brenda Spencer, Internal Medicine Location: MICU, Bed 4 Male Caucasian DOB: 8/2/ (178 cm), 163 lbs. (73.94 kg) John Williams is a 27 year old white male admitted to the hospital on 8/01/94 for chronic gastric pain. His medical history includes asthma for many years, and since admission, he is on (0.65 mg/kg/hr) TheoDur 300 mg Q8H (7:00 am; 3:00 pm; 11:00 pm) to control shortness of breath and wheezing. He had received 9 days treatment of a 10-day Erythromycin regimen when he was admitted (07/24/94, 7:00 am to 08/02/94, 11:00 pm). The physician is confused by the patient s erratic theophylline levels and has requested kinetic consults on August 3 (2:45 pm) and August 6, 1994 (3:00 pm). August 3, 1994 The patient is now off Erythromycin therapy. Theophylline half-life and dosing requirements will change. Serum drug concentration obtained today at 2:30 pm is 8.3µg/ml. Check t ½ before and after curve fitting. Enter New Patient in Patient Assessment: Select Patient / New Patient and enter all information. Document the Patient s Baseline Condition (OPTIONAL): Select Profiles / Drug Usage. Click on New. Select the drug, enter the therapy start date, and select the physician. Click on OK. Click on Baseline and respond to the criteria accordingly. A sample of the baseline report is attached. Define Simulation Information: Access the Kinetics System. Select Simulation / New Simulation. Select the appropriate drug (Theophylline), enter the start date (08/01/94), the start time (07:00 am), and accept the default starting concentration (0). If you do not wish to enter previous dosage regimens, you may enter the last known drug concentration in this field. Click on OK. Select the indication (Asthma) and click on OK. Define Drug Interaction: Select Patient Info / Drug Interactions. Select the drug (Erythromycin), the start date (7/24/94, which will convert to 8/1/94 because that is the start of the simulation), the start time (07:00 am), the end date (08/02/94), and the end time (11:00 pm). Click on Add. Click on OK. Enter Previous Dosage Regimens: Select Kinetics / Dosage Regimens. Select the product (Theo-Dur), enter the dose (300), the interval (8), and the number of doses given since admission to the hospital (7). Click on Add. The Meals and Dosing screen will appear. Choose Unknown and click on OK. A message will appear notifying you that regimens will be split, in this case because the Erythromycin drug interaction ended on 8/2/94, during the Theo-Dur therapy. Click on OK. Click on OK again and the regimens will graph. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 3

4 Step 9. Enter Serum Drug Concentrations: Select Kinetics / Serum Drug Concentrations. Enter the date, time, and value of the SDC obtained today. Click on Add. Click on OK. The SDC will appear as a triangle on the graph. Curve Fit the Serum Drug Concentration: Select Kinetics / Curve Fitting. Select the partition (B, partition was formed because of interaction), the Analysis Type (Single Point), and the SDC from the list. Click on Analyze. Click on Accept. A message will appear notifying you that if new partitions are formed following this analysis, they will revert to literature values (until SDCs are curve fit in the new partition). SDCs can be only be curve fit in one partition at a time. Click on OK. Click on OK again and the SDC will be curve fit. Obtain Rx Recommendations: Select Kinetics / Dosing Regimens. Select the route (PO), select the product (Theo-Dur), and click on Rx Rec. Choose Unknown at Meals and Dosing screen and click on OK. Select the 397 mg Q8 dose option and click on Customize Rx. Customize the dose to 400 mg and click on OK. Click on Select Rx and click on OK to add it to the list of dosage regimens. Click on OK to add it to the graph. Generate Consult Report: Select Reports / Perform All Above. Select Regimens 1 and 2 as current therapy and click on OK. Select Regimen 3 as your recommendation and click on OK. Enter any comments and click on OK. Select the appropriate layout options and click on OK. The consult report will now generate. Offer your recommendations to the physician. Save simulation. August 6, 1994 On 8/4/94 at 7:00 am John was started on Cimetidine 400 mg BID for active peptic ulcer disease. Generate a new dosage regimen. Serum drug concentration obtained today at 2:45 pm is 19.1µg/ml. Open Patient s Kinetics Simulation: Select Simulation / Open Simulation. Select the last simulation and click on OK. Simulations may be sorted by physician, drug, or date. Define Drug Interaction: Select Patient Info / Drug Interactions. Select the drug (Cimetidine >=800 mg/day), enter the start date (08/04/94), and enter the start time (07:00 am). Click on Add. A message will appear notifying you that this interaction s effects are based on literature values (you will want to enter SDCs and curve fit them in this partition for the most accurate results). Click on OK. A message will appear notifying you that the regimen will be split. Click on OK. Update Previous Regimen: Select Kinetics / Dosage Regimens. The physician had accepted your request and the patient has been given 9 doses instead of 7. Select the last regimen from the list and click on Edit. Enter 7 in the #doses field ( regimens were split: 2+7=9). Click on Replace and choose Unknown for Meals and Dosing screen. Click on OK and the regimen will be updated. Click on OK again and the graph will be updated. Enter Serum Drug Concentrations: Select Kinetics / Serum Drug Concentrations. Enter the date, time, and value of the SDC obtained today. Click on Add. Click on OK. The SDC will appear as a triangle on the graph. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 4

5 Curve Fit the Serum Drug Concentrations: Select Kinetics / Curve Fitting. Select the partition (C, partition was formed because of interaction), the Analysis Type (Single Point), and the SDC from the list. Click on Analyze. Click on Accept. A message will appear notifying you that if new partitions are formed following this analysis, they will revert to literature values (until SDCs are curve fit in the new partition). SDCs can be only be curve fit in one partition at a time. Click on OK. Click on OK again and the SDC will be curve fit. Obtain Rx Recommendations: Select Kinetics / Dosage Regimens. Select the route (PO), the product (Theo-Dur), and click on Rx Rec. Choose Unknown for meals screen and click on OK. Select the Hold option and click on Customize Rx. Enter 8 in the field and click on OK. Select the newly customized hold option and click on Select Rx. Select the 226 mg Q8 option and click on Customize Rx. Enter 250 in the dose field and click on Calculate to view the difference between the initial and final parameters. Click on OK. Select the 250 mg option from the list and click on Select Rx. Click on OK. Click on OK again to add the regimens to the graph. Generate a Consult: Select Reports / Perform All Above. Select the appropriate options and offer your recommendations to the physician. A sample of the consult is attached. Save the simulation. Document the Patient s Interim/Final Condition (OPTIONAL): Access Patient Assessment. Select Profiles / Drug Usage. Select the appropriate therapy and click on Int/Final. Respond to the criteria accordingly. A sample of the final report is attached. Wheezing has ceased and patient has no complaints. He will be discharged today. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 5

6 3. Mary J. Jones MR #: Account #: Admission Date: 8/13/94 Physician: John Smith, Internal Medicine Location: 6 East, Room 665, Bed A Female Caucasian DOB: 6/20/ (170 cm), 125 lbs (56.70 kg) Mary J. Jones is a hospitalized patient being treated for an infection with gram negative rods. The patient initially was admitted with peritonitis and ambulatory dialysis. After culture and sensitivity results, gentamicin had been chosen to treat the infection and was started at a dose of 80 mg IVB over 30 minutes every 8 hours beginning at 8:00 am; 8/13/94. The patient was well hydrated during therapy to minimize risk of toxicity. On 8/15/94 patient continues to complain of malaise and loss of appetite. Patient has elevated WBC and temperature of 101º F. The measured peak concentration at steady state was 10.2µg/mL (8/15/94; 9:00 am) and a trough concentration was 6.2µg/mL (8/15/94; 3:30 pm). The patient has deteriorating renal function (8/13/94; 08:00 am; SCr = 2.0 mg%) and therapy requires intervention by pharmacist since dosage and monitoring have been unsatisfactory. Estimated creatinine clearance had not been calculated prior to the start of therapy. Enter New Patient in Patient Assessment: Select Patient / New and enter all patient information. Document the Patient s Baseline Condition (OPTIONAL): Select Profiles / Drug Usage. Click on New. Select the drug, enter the therapy start date, and select the physician. Click on OK. Click on Baseline and respond to the criteria accordingly. A sample of the baseline report is attached. Define Simulation Information: Access the Kinetics System. Select Simulation / New Simulation. Select the drug (Gentamicin), enter the start date (8/13/94), the start time (08:00 am), and accept the default starting concentration (0). If you do not wish to enter previous dosage regimens, you may enter the last known drug concentration in this field. Click on OK. Select the indication (Peritonitis) and click on OK. Enter Renal Function Values: Select Kinetics / Renal Function. Enter the serum creatinine information described in the paragraph above. Click on Add. Click on OK. Enter Previous Dosage Regimens: Select Kinetics / Dosage Regimens. Enter the gentamicin dosing information described in the paragraph above. Be sure to enter the correct number of doses given (started on 8/13/94 at 8:00 am and currently 8/15/94 at about 4:00 pm). Click on Add. Click on OK. Enter Serum Drug Concentrations: Select Kinetics / Serum Drug Concentrations. A peak and trough concentration were obtained. Enter the information described in the paragraph above. Be sure to click on Add after entering each SDC. Click on OK. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 6

7 Step 9. Curve Fit the Serum Drug Concentrations: Select Kinetics / Curve Fitting. Select the Analysis Type (Simplex) and select the SDCs from the list. Click on Analyze. Click on Accept. Click on OK and the SDCs will be curve fit. Obtain Rx Recommendations: Select Kinetics / Dosage Regimens. Click on Rx Rec. Select the Hold option and click on Customize Rx. Enter 24 in the field to make it more practical and click on OK. Click on Select Rx. Now you will recommend two possible dosing regimens. Select the 81 mg Q24 option and click on Customize Rx. Enter 80 in the dose field and click on OK. Click on Select Rx. Now select the 113 mg Q48 option and click on Customize Rx. Enter 120 in the dose field and click on OK. Click on Select Rx. Click on OK to add them to the list of regimens on the Dosage Regimens screen. Click on OK to update the graph. Quick View the Regimens (OPTIONAL): You may quickly view each graphed dosing regimen by clicking on the up and down arrow buttons located to the right of the Regimen box at the top of the screen. The Regimen box will display the drug, route, dose, duration, interval, and number of doses for each regimen. The Peak and Trough boxes will display the corresponding peak and trough values for each regimen. Step 10. Generate a Consult Report: Select Reports / Perform All Above. Select regimen 1 as the current regimen. Click on OK. Select regimens 2, 3, and 4 as your recommendations. Click on OK. Select or enter any free text notes. Click on OK. Select the appropriate layout options and click on OK. (The checked items will be included on the report. The order of the items is customized utilizing the Consult Format option under the Tools menu). The consult will generate. A sample of the consult report is attached. Step 11. Document Pharmacy Interventions (OPTIONAL): Select Pharmacist Actions / Intervention. Suppose the physician decided to implement your 80 mg Q24 recommendation. Enter the date the recommendation was implemented, select Increased for Dosage Interval and select Accept for Physician Action Toward Recommendation. Select your name from the Pharmacist list or add it in the Consult Layout screen if it does not exist. Click on OK. Save the simulation. Step 12. Document the Patient s Interim/Final Condition (OPTIONAL): Access Patient Assessment. Select Profiles / Drug Usage. Select the current therapy and click on Int/Final. Respond to the criteria accordingly. A sample of the final report is attached. After 48 hours, patient has responded well to new regimen. WBC are within normal limits and patient is afebrile, daily serum creatinine remains at 2.0. Negative cultures noted after 7 days of therapy. Patient understands therapy benefits and feels the antibiotics have cleared her infection. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 7

8 4. Kenneth J. McAllen MR #: Account #: Admission Date: 01/25/94 Physician: Brenda Spencer, Internal Medicine Location: 5 West, Room 508 Male Caucasian DOB: 5/12/ (180 cm) 160 lbs. (72.58 kg) Kenneth McAllen is a 68 year old man admitted on 1/25/94 for an electrolyte imbalance. His medical history includes chronic renal disease and a positive history of ETOH abuse. Initial lab results included a BUN of 30, SCr of 1.7 mg/dl (1/25/94; 8:00 am), blood C&S positive for a mixed injection with sensitivities to aminoglycosides and vancomycin. His current medications include Gentamicin 80 mg Q12H (over 30 min.), which he has been on for 2 days (started 1/25/94 at 8:00 am). Secondary to positive culture and sensitivity showing penicillin resistant staph and gram negative rods, he was concomitantly started on Vancomycin 1 gm (over 60 min.) Q12H with the physician ordering Vancomycin SDCs after the 4th dose and follow up cultures. January 27, 1994 The vancomycin peak SDC 3.5 hrs. post 5th dose (1/27/94; 11:30 am) was 26.8 µg/ml, while the trough SDC 11.8 hrs. post 5th dose was 19.0 µg/ml (1/27/94; 7:48 pm). The patient has developed a maculopapular rash. It was observed this morning at about 8:00. Enter New Patient in Patient Assessment: Select Patient / New Patient and enter all information. Document Patient Allergies (OPTIONAL): Select Profiles / Patient Allergies. A list of chemical classes is displayed. Select Penicillins (you may enter the first few letters in the field to access the first chemical class that begins with those letters). Click on Include. More than one allergy can be included. Click on Save to exit. Document the Patient s Baseline Condition (OPTIONAL): Select Profiles / Drug Usage. Click on New. Select the drug, enter the therapy start date, and select the physician. Click on OK. Click on Baseline and respond to the criteria accordingly. A sample of the baseline report is attached. Define Simulation Information: Access the Kinetics System. Select Simulation / New Simulation. Select the drug (Vancomycin), enter the start date (01/25/94), enter the start time (08:00 am), and accept the default starting concentration (0). If you do not wish to enter previous dosage regimens, you may enter the last known drug concentration in this field. Click on OK. Select the indication (Staphylococcal or Streptococcal Infection in Patient Allergic to Penicillin) and click on OK. Define Drug Interaction: Select Patient Info / Drug Interactions. Select the drug (Gentamicin), enter the start date (01/25/94), and the start time (08:00 am). Click on Add. Click on OK. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 8

9 Step 9. Enter Renal Function Values: Select Kinetics / Renal Function. Enter the serum creatinine information described in the paragraph above. Click on Add. Click on OK. Enter Previous Dosage Regimens: Select Kinetics / Dosage Regimens. Enter the vancomycin dosing information described in the paragraph above. Be sure to enter the dose in mg and enter the correct number of doses given (started 1/25/94 at 8:00 am and currently 1/27/94 at about 8:00 pm). Click on Add. Click on OK. Enter Serum Drug Concentrations: Select Kinetics / Serum Drug Concentrations. Peak and trough concentrations were obtained. Enter the information described in the paragraph above. Be sure to click on Add after entering each SDC. Click on OK. Curve Fit Serum Drug Concentrations: Select Kinetics / Curve Fitting. Select the Analysis Type (Bayesian) and select the SDCs from the list. Click on Analyze. Click on Accept. Click on OK and the SDCs will be curve fit. Step 10. Obtain Rx Recommendations: Select Kinetics / Dosage Regimens. Click on Rx Rec. Select the Hold option and click on Customize Rx. Enter 24 in the field to make it more practical and click on OK. Click on Select Rx. Now select the 1126 mg Q24 option and click on Customize Rx. Enter 1200 in the dose field and click on OK. Click on Select Rx. Click on OK to add them to the list of regimens on the Dosage Regimens screen. Click on OK to update the graph. Step 11. Generate Kinetics Consult Report: Select Reports / Perform All Above. Select regimen 1 as the current regimen and click on OK. Select regimens 2 and 3 as your recommendations and click on OK. Select or enter any free text notes and click on OK. Select the appropriate layout options and click on OK. The consult will generate. A sample of the consult report is attached. Step 12. Document Pharmacy Interventions (OPTIONAL): Select Pharmacist Actions / Intervention. Suppose the physician implemented your recommendations. Enter the date the recommendation was implemented (01/27/94), select Increased for Dosage Amount, select Increased for Dosage Interval, and select Accept for Physician Action Toward Recommendation. Select your name from the Pharmacist list or add it in the Consult Layout screen if it does not exist. Click on OK. Save the simulation. February 1, 1994 Vancomycin therapy discontinued. Gentamicin therapy will continue through February 5. Document Patient s Interim/Final Condition (OPTIONAL): Access Patient Assessment. Select Profiles / Drug Usage. Select the current therapy and click on Edit. Enter the therapy stop date (02/01/94) and click on OK. Click on Int/Final. Respond to the criteria accordingly. A sample of the final report is attached. Save the patient file. D:\Pha5128_Dose_Opt_II\4-case\Cs-4-01.doc 9